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Genesig® COVID-19 3G (CE IVD)
Genesig® COVID-19 3G (CE IVD) Genesig® COVID-19 3G (CE IVD)

Productos - Kits de Diagnóstico - Human Pathogen

Genesig® COVID-19 3G (CE IVD)

Genesig Real-Time PCR Coronavirus (COVID-19) CE IVD Kit


Genesig Real-Time PCR Coronavirus (COVID-19) CE IVD Kit, genesig COVID-19 2G and genesig COVID-19 3G are two and three-gene assays for detection of the ORF1ab, M gene, and S gene targets of SARS-CoV-2.

 

Three-gene assay fulfils certain international testing requirements, including Fit to Fly Certificate, Test to Release and US Food and Drug Administration regulations.

 

KEY FEATURES

 

  • High priming efficiency
  • Accurate controls to confirm extraction, and assay validity
  • Lyophilised components for ambient shipping
  • 96 Reactions
  • Results in under 2 hours

 

Three-gene assay

  • Results in under 3 hours
  • Multi-platform capability
Product Name genesig® Real-Time PCR Coronavirus (COVID-19) CE IVD Kit genesig® COVID-19 2G genesig® COVID-19 3G
Product Code Z-path-COVID-19-CE D00011 D00063
Pack Size 96 96 96
Sensitivity 100% 100% 99.50%
Specificity 99.18% 100% 99.70%
Accuracy N/A N/A N/A
Sample Type Combined Nasal/Oropharyngeal swabs Nasopharyngeal, Oropharyngeal and Sputum Combined Nasal/Oropharyngeal swabs
Time to Result 60 mins 60 mins 60 mins
Limit of Detection 0.33 copies/µl <0.40 copies/µl 1 copies/µl
Storage Frozen Frozen Frozen



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